多孔钽棒改善股骨颈骨折术后股骨头缺血性坏死患者的髋关节功能:随机对照临床试验方案

Porous tantalum rod implantation improves the hip joint function of patients with avascular necrosis of the femoral head after femoral neck fracture surgery: study protocol for a randomized controlled trial

背景:股骨颈骨折后由于股骨头血供不足而出现缺血性坏死,可增加治疗困难并明显影响髋关节功能的恢复。髓芯减压植骨治疗股骨头缺血性坏死是常用的治疗方法,多孔钽棒是一种类似于骨小梁结构的金属支撑物,用于支撑于骨坏死负重区,阻止坏死区的塌陷,其治疗股骨头缺血性坏死的早期临床效果较理想,目前有关多孔钽棒置入治疗股骨颈骨折术后股骨头缺血性坏死的随机对照研究较少。目的:观察髓芯减压后置入多孔钽棒改善股骨颈骨折术后股骨头缺血性坏死患者髋关节功能的效果。方法:研究为前瞻性、单中心、随机对照、开放性临床试验,在中国青海省西宁市,青海大学附属医院创伤骨科完成。将纳入试验的股骨颈骨折术后股骨头缺血性坏死患者100例随机分为2组,每组50例,观察组髓芯减压后采用多孔钽棒置入治疗,对照组采用髓芯减压治疗,随访1年。试验主要结局为术后12个月患者髋关节功能Harris评分为优的例数百分比,评估患者髋关节功能恢复情况。次要结局为术前、术后1,6个月的髋关节功能Harris评分为优的患者例数百分比;术前、术后1,6,12个月的目测类比评分评估患者疼痛情况;术后6,12个月评价患者股骨头塌陷、假体松动和假体周围感染例数百分比,评估材料和宿主的生物相容性;术后6,12个月并发症发生率,评估置入后的安全性。试验经中国青海大学附属医院医学伦理委员会批准(审批号:QHY1016B)。研究符合世界医学会指定的《赫尔辛基宣言》的标准。参与者本人对试验内容和治疗过程均知情同意,并签署知情同意书。讨论:试验旨在验证以多孔钽棒置入治疗股骨颈骨折术后股骨头缺血性坏死过程中,植入物的生物相容性及治疗效果,为股骨颈骨折术后股骨头缺血性坏死的治疗提供有一种新的有说服力的外科治疗方法。

BACKGROUND：After femoral neck fracture, avascular necrosis of the femoral head occurs because of insufficient blood supply to the femoral head, resulting in increased difficulty in treatment, and greatly influencing the recovery of hip joint function. Core decompression and bone grafting is a common treatment method of avascular necrosis of the femoral head. A porous tantalum rod is a bone trabecula-like metal implant that is used to support weight-bearing area of necrotic bone, prevent further colapse of the necrotic area, and thereby exhibits favorable effects in the early treatment of avascular necrosis of the femoral head. Few randomized controled studies are reported on porous tantalum rod implantation for treatment of avascular necrosis of the femoral head after femoral neck fracturesurgery. OBJECTIVE：To investigate whether porous tantalum rod implantation can improve the hip joint function of patients with avascular necrosis of the femoral head subjected to femoral neck fracturesurgery. METHODS：This is a prospective, single-center, randomized, controled, open trial, which wil be performed in the Department of Orthopedic Trauma, Qinghai University Affiliated Hospital, China. A total of 100 patients with avascular necrosis of the femoral head subjected to femoral neck fracturesurgerywil be randomly assigned to undergo core decompression and porous tantalum rod implantation （experimental group,n=50） or only core decompression （control group,n=50）. Al patients wil be folowed up for 1 year. Primary outcome measure is the percentage of patients whose hip joint function is graded as excelent as per Harris scores 12 months after surgery in total patient number in each group, which wil be used to evaluate the recovery of hip joint function. Secondary outcome measures include （1） the percentage of patients with excelent hip joint function 1 and 6 months after surgery in total patient number in each group;（2） Visual Analogue Scale spine score prior to and 1, 6 and 12 months after surgery, which wil be used to evaluate the severity of pain; （3） the percentage of patients presenting with femoral head colapse, prosthesis loosening and peri-prosthesis infection 6 and 12 months after surgery, which wil be used to evaluate the biocompatibility of biomaterial with host;and（4） incidence of complications 6 and 12 months after surgery, which wil be used to evaluate the safety of porous tantalum rod implantation. This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital of China （approval number：QHY1016B） and wil be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment wil be obtained from each patient. DISCUSSION：This study is powered to validate the biocompatibility and therapeutic effects of porous tantalum rods in the treatment of avascular necrosis of the femoral head after femoral neck fracture surgery, which hopes to provide a novel persuasive surgical treatment methodforthis disease.